Key Tronic Corp. - FDA 510(k) Cleared Devices

Key Tronic Corp., is a global contract manufacturer specializing in electronics assembly, injection molding, metal fabrication, and full product assembly. The company operates manufacturing facilities across multiple continents, including a registered FDA facility in McHenry, US, and serves diverse markets including medical devices, telecommunications, aerospace, and industrial applications.

Key Tronic Corp. has received 1 FDA 510(k) clearance from 1 total submission. The company's regulatory history in medical devices focuses on Neurology devices, with clearance dating to 1979. This represents a historical regulatory record; the company has not received FDA 510(k) clearances in more than five years and should be treated as an inactive participant in the medical device clearance database.

The company's medical device manufacturing capabilities include design and engineering support, precision assembly, and quality assurance aligned with regulatory standards. Keytronic's experience spans prototyping through high-volume production for medical applications, supported by global manufacturing infrastructure and compliance expertise.

Explore the complete regulatory record, including device names, product codes, and clearance dates in the database.